UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018151 |
|---|---|
| Receipt number | R000021023 |
| Scientific Title | Effort of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney and vascular diseases in patients with type 2 diabetes mellitus. |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2018/05/11 14:39:38 |
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Basic information
Public title
Effort of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney and vascular diseases in patients with type 2 diabetes mellitus.
Acronym
Effort of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney and vascular diseases in patients with type 2 diabetes mellitus.
Scientific Title
Effort of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney and vascular diseases in patients with type 2 diabetes mellitus.
Scientific Title:Acronym
Effort of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney and vascular diseases in patients with type 2 diabetes mellitus.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We prospectively investigated efforts of canagliflozin on metabolic syndrome parameters and biomarkers of heart, kidney, and vascular diseases in patients with type 2 diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) HbA1c, fasting blood glucose, HOMA-R and HOMA-beta
2) Body weight, adiponectin, triglyceride, remnant-like particle cholesterol and apoB-48
3) BNP and troponin
4) Cystatin C, albuminuria, L-FABP and NGAL
5) High-sensitivity CRP
6) Symptoms and laboratory test values
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) HbA1c >=6.5% and <10%, and a fasting plasma glucose (FPG) of <=270 mg/dL (HbA1c >=7.0% in case of having sulfonylureas).
2) BMI >=25kg/m2.
3) Patients receiving sulphonylureas, thiazolidinediones, biguanides and/or DPP4 inhibitors more than 8 weeks
4) Patients with blood pressure >=130/80 mmHg (systolic/diastolic).
5) Patients who have given written informed consent atenrollment.
Key exclusion criteria
1) Patients with allergy for canagliflozin.
2) Patients with severe ketosis, diabetic coma, diabetic precoma, or type 1 diabetes mellitus.
3) Patients with severe renal dysfunction (eGFR<30) including the patient who needs haemodialysis or peritoneal dialysis.
4) Patients with severe infection disease or serious trauma.
5) Patient with the history of an urinary tract infection or genital infection.
6) Pregnant women and women suspected of being pregnant.
7) Women during lactation.
8) Patient who had myocardial infarction or cerebral infarction within 3 months before the informed consent.
9) Patients with insulin therapy.
10) Patients whose doctor judges to unfit for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Ishii |
Organization
Fujita Health University School of Medicine
Division name
Department of Joint Research Laboratory of Clinical Medicine
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake 470-1192, Japan.
TEL
81-0562-93-2312
jishii@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Naruse |
Organization
Fujita Health University School of Medicine
Division name
Department of Joint Research Laboratory of Clinical Medicine
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake 470-1192, Japan.
TEL
81-0562-93-2312
Homepage URL
hnaruse@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2018 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021023
